What is NDC 55111-163?

55111-163 is the product NDC for Olanzapine, Olanzapine 2.5 mg/1 tablet, film coated, listed with the FDA by Dr. Reddy's Laboratories Ltd.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Dr. Reddy's Laboratories Ltd., NDC labeler code 55111. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Olanzapine?

205 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Olanzapine NDC 55111-163 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-163Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0163Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
55111-163-01	5511101630155111016301	100 TABLET, FILM COATED in 1 BOTTLE (55111-163-01)Marketed from Apr 23, 2012
55111-163-05	5511101630555111016305	500 TABLET, FILM COATED in 1 BOTTLE (55111-163-05)Marketed from Apr 23, 2012
55111-163-30	5511101633055111016330	30 TABLET, FILM COATED in 1 BOTTLE (55111-163-30)Marketed from Apr 23, 2012
55111-163-78	5511101637855111016378	10 BLISTER PACK in 1 CARTON (55111-163-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-163-79)Marketed from Apr 23, 2012

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Olanzapine
Generic name (nonproprietary): olanzapine
Active ingredients: Olanzapine — 2.5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Dr. Reddy's Laboratories Ltd.NDC labeler code 55111
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076255
Marketing start: Apr 23, 2012
Listing expires: Dec 31, 2027
Identifiers: Product ID 55111-163_ba26436d-7009-476f-23b0-45676a0e7805SPL ID ba26436d-7009-476f-23b0-45676a0e7805SPL set ID 9a57a63e-f856-aafa-037a-c08f2fea6496RxCUI 200034UNII N7U69T4SZR
Pharmacologic class: Atypical Antipsychotic

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N455111016301 followed by a unit qualifier and the quantity

Package 55111-0163-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Oct 3, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

Olanzapine is an atypical antipsychotic indicated: As oral formulation for the: • Treatment of schizophrenia. ( 1.1 ) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1 ) Adolescents (ages 13 to 17): Efficacy was established in one 6week trial in patients with schizophrenia (14.1) . The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1) • Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2 ) Adults: E…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55111-163

What is NDC 55111-163?: 55111-163 is the product NDC for Olanzapine, Olanzapine 2.5 mg/1 tablet, film coated, listed with the FDA by Dr. Reddy's Laboratories Ltd.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Olanzapine.
What is the active ingredient?: Olanzapine.
Who is the labeler?: Dr. Reddy's Laboratories Ltd., NDC labeler code 55111. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Olanzapine?: 205 other product NDCs are listed under this name. See all Olanzapine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Olanzapine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0690	67046-0690-03
Olanzapine	Olanzapine 2.5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4729	70518-4729-00
Olanzapine	Olanzapine 2.5 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-6693	55154-6693-00
olanzapine	Olanzapine 15 mg/1	Tablet, Orally disintegratingOral	Bionpharma Inc.	69452-563	69452-0563-13
olanzapine	Olanzapine 5 mg/1	Tablet, Orally disintegratingOral	Bionpharma Inc.	69452-561	69452-0561-13
olanzapine	Olanzapine 10 mg/1	Tablet, Orally disintegratingOral	Bionpharma Inc.	69452-562	69452-0562-13
olanzapine	Olanzapine 20 mg/1	Tablet, Orally disintegratingOral	Bionpharma Inc.	69452-564	69452-0564-13
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-061	87441-0061-01
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-062	87441-0062-01
Olanzapine	Olanzapine 20 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0072	67046-0072-03

All 206 Olanzapine NDCs

Other NDCs under ANDA 076255

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 076255
Product	Strength	Form · route	Labeler	Product NDC
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6376
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6377
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Dr. Reddy's Laboratories Inc.	43598-164
Olanzapine	Olanzapine 7.5 mg/1	Tablet, Film coatedOral	Dr. Reddy's Laboratories Inc.	43598-165
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	Dr. Reddy's Laboratories Inc.	43598-166
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-6881
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-6889
Olanzapine	Olanzapine 7.5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0363
Olanzapine	Olanzapine 2.5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0539
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0540
Olanzapine	Olanzapine 2.5 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-525
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-723
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-740
Olanzapine	Olanzapine 2.5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4012
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8722
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0110
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1605
Olanzapine	Olanzapine 7.5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1611
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1635
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1764

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